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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024396-12 | EudraCT Number | ||
| EudraCT 2010-024396-12 | Registry Identifier | EudraCT |
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This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEZ235 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEZ235 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) | every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival) | every 8 weeks | |
| evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious). |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital & Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Highlands Oncology Group |
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| Treatment start until 30 days after the last dose |
| Fayetteville |
| Arkansas |
| 72703 |
| United States |
| City of Hope Medical center | Duarte | California | 91010 | United States |
| Holy Cross Hospital | Silver Spring | Maryland | 20910-1484 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Morriswon Memorial Hospital | Morristown | New Jersey | 07960 | United States |
| Carolinas Healthcare Systems | Charlotte | North Carolina | 28203 | United States |
| Cancer Centers of North Carolina | Raleigh | North Carolina | 27607 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73126-0901 | United States |
| GHS | Danville | Pennsylvania | United States |
| Sarah Gautam Rau | Nashville | Tennessee | 37203-1197 | United States |
| Texas Oncology, P.A. | Austin | Texas | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| STOH | San Antonio | Texas | United States |
| Pacific Gynecology Specialists | Seattle | Washington | 98104 | United States |
| Cancer Care Northwest | Spokane | Washington | 99202 | United States |
| Novartis Investigative Site | Rio de Janeiro | Brazil |
| Novartis Investigative Site | São Paulo | Brazil |
| Novartis Investigative Site | Hamilton | Canada |
| Novartis Investigative Site | Montreal | Canada |
| Novartis Investigative Site | Toronto | Canada |
| Novartis Investigative Site | Vancouver | Canada |
| Novartis Investigative Site | Bordeaux | France |
| Novartis Investigative Site | Caen | France |
| Novartis Investigative Site | La Roche-sur-Yon | France |
| Novartis Investigative Site | Le Mans | France |
| Novartis Investigative Site | Lyon | France |
| Novartis Investigative Site | Marseille | France |
| Novartis Investigative Site | Nice | France |
| Novartis Investigative Site | Paris | France |
| Novartis Investigative Site | Saint-Brieuc | France |
| Novartis Investigative Site | Toulouse | France |
| Novartis Investigative Site | Berlin | Germany |
| Novartis Investigative Site | Cologne | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | Germany |
| Novartis Investigative Site | Jena | Germany |
| Novartis Investigative Site | Lübeck | Germany |
| Novartis Investigative Site | Mainz | Germany |
| Novartis Investigative Site | München | Germany |
| Novartis Investigative Site | Aviano | Italy |
| Novartis Investigative Site | Barcelona | Italy |
| Novartis Investigative Site | Bologna | Italy |
| Novartis Investigative Site | Brescia | Italy |
| Novartis Investigative Site | Capmobso | Italy |
| Novartis Investigative Site | Milan | Italy |
| Novartis Investigative Site | Modena | Italy |
| Novartis Investigative Site | Naples | Italy |
| Novartis Investigative Site | Roma | Italy |
| Novartis Investigative Site | Aichi | Japan |
| Novartis Investigative Site | Hyōgo | Japan |
| Novartis Investigative Site | Tokyo | Japan |
| Novartis Investigative Site | Środa Wielkopolska | Poland |
| Novartis Investigative Site | Warzawa | Poland |
| Novartis Investigative Site | Saint Petersburg | Russia |
| Novartis Investigative Site | Singapore | Singapore |
| Novartis Investigative Site | Madrid | Spain |
| Novartis Investigative Site | Oviedo | Spain |
| Novartis Investigative Site | Valencia | Spain |
| Novartis Investigative Site | Istanbul | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C531198 | dactolisib |
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